FDA Device Recall Z-0021-2015: Biomet, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0021-2015.

Recall Res Number

Z-0021-2015

Recalling Firm / Manufacturer

Biomet, Inc.

FEI Number

1825034

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-09-17

Date Posted

2014-10-06

Date Terminated

2015-07-14

Product Code

HTO

Event Number

69280

Product Quantity

Product Description Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

Reason for Recall Investigation determined that units supplied were missing the 4x21 degree helix angle.

Action Details On September 17, 2014, "URGENT MEDICAL DEVICE RECALL NOTICE" was sent to the consignee Biomet Global Supply Chain Center (GSCC) by email and FedEx. GSCC notified all of the customers within Europe, the Middle East, and Asia that received the affected product. The recall notification included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call (574) 372-1570.

Distribution Pattern International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.

Code Information / Serial Numbers Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290

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Medical Device Recall: Z-0021-2015

Recall Parameters & Description

Related Establishments / Registrations

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